Dapagliflozin

FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. …

• Assess renal function prior to initiation and then as clinically indicated
• Assess volume status and correct volume depletion before initiating. • To improve glycemic control, the recommended starting dosage is 5 mg orally once daily
• Dosage can be increased to 10 mg orally once daily for additional glycemic control. • For all other indications, the recommended dosage is 10 mg orally once daily. • See full prescribing information for dosage recommendations in patients with renal impairment. • Withhold FARXIGA for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting
• Testing Prior to Initiation of FARXIGA • Assess renal function prior to initiation of FARXIGA and then as clinically indicated [see Warnings and Precautions ]. • Assess volume status
• In patients with volume depletion, correct this condition before initiating FARXIGA [see Warnings and Precautions and Use in Specific Populations ]
• Recommended Dosage for Glycemic Control
• In Adults and Pediatric Patients Aged 10 Years and Older with Type 2 Diabetes Mellitus
• In adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, the recommended starting dosage of FARXIGA is 5 mg orally once daily to improve glycemic control
• For additional glycemic control, the dosage can be increased to 10 mg orally once daily. …

Tablets: • 5 mg, yellow, biconvex, round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. • 10 mg, yellow, biconvex, diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. • Tablets: 5 mg and 10 mg ( 3 )

• The safety and effectiveness of FARXIGA as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established
• In pediatric patients aged 10 years and older. Use of FARXIGA for this indication is supported by a 26-week placebo-controlled trial with a 26-week extension in 157
• Pediatric patients aged 10 to 17 years with type 2 diabetes mellitus, pediatric pharmacokinetic data, and trials
• In adults with type 2 diabetes mellitus [see Clinical Pharmacology and Clinical Studies ] . …

No FARXIGA dosage change is recommended based on age. A total of 1424 (24%) of the 5936 FARXIGA-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical trials assessing the efficacy of FARXIGA in improving glycemic control in type 2 diabetes mellitus. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, inform them that using FARXIGA can increase their risk of life-threatening diabetic ketoacidosis
• For all other patients, inform them that FARXIGA can cause potentially fatal ketoacidosis and that type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are risk factors. …

• FARXIGA is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA
• Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with FARXIGA [see Adverse Reactions ] . • History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA

Table 4: Clinically Relevant Interactions with FARXIGA Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when FARXIGA is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions (5.4) ]. Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during FARXIGA initiation and dosage changes. …

• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue FARXIGA if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. (5.1) • Volume depletion: Before initiating FARXIGA, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. …

The following important adverse reactions are described below and elsewhere in the labeling: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Volume Depletion [see Warnings and Precautions (5.2) ] • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.3) ] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] • Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, …

8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. …

There were no reports of overdose during the clinical development program for FARXIGA. In the event of an overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status. The removal of dapagliflozin by hemodialysis has not been studied.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.